食品和药物管理局批准对带有ESR1突变的晚期乳腺癌使用Inloriyo口服药物,表明进展风险低38%。 FDA approves oral drug Inluriyo for advanced breast cancer with ESR1 mutations, showing 38% lower progression risk.

美国食品和药物管理局批准Inluriyo (imlunestrant) 用于先前内分泌治疗后进展的先进或转移性雌激素受体阳性,HER2- 阴性乳腺癌,其原因是ESR1突变. The FDA has approved Inluriyo (imlunestrant) for adults with advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer driven by ESR1 mutations who have progressed after prior endocrine therapy. 根据MEBER-3试验,该药物比标准疗法降低了38%的疾病发展或死亡风险,中位无进展存活率为5.5个月,而中位无进展存活率为3.8个月。 Based on the EMBER-3 trial, the drug reduced the risk of disease progression or death by 38% compared to standard therapy, with a median progression-free survival of 5.5 months versus 3.8 months. 每天口服一次,由卫兵360CDX化验支持,供病人选择。 It is taken orally once daily and is supported by the Guardant360 CDx assay for patient selection. 常见副作用包括疲劳、恶心、腹泻和低血红蛋白,大多数不良事件温和。 Common side effects include fatigue, nausea, diarrhea, and low hemoglobin, with most adverse events being mild. 该药物为注射治疗提供了方便的全方位替代疗法,预计不久将在美国提供。 The drug offers a convenient all-oral alternative to injectable treatments and is expected to be available in the U.S. soon.